A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy

Inclusion Criteria:

- Written informed consent must be obtained prior to all study specific screening
procedures, as close to the start of the screening period as possible.

- Presence of clinically (local Achilles tendon pain on tendon-loading activities,
pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and
ultrasound (local tendon thickening with hypoechogenicities and irregular fibre
orientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptoms
present ≥8 weeks but <12 months at screening.

- The Achilles tendinopathy must have been refractory to at least 6 weeks of
conservative treatment (physiotherapy, NSAIDS, RICE), but participants do not need
to be in physiotherapy at the time of study entry.

Exclusion Criteria:

- Medical condition that would affect safety of peritendon injection (e.g., peripheral
vascular disease, use of anticoagulant medication)

- History of recurrent, acute, symptomatic infections, including outbreaks of oral or
genital herpes (> 2 symptomatic infections or >2 courses of anti-infective
treatments required in the last 6 months; active systemic infection during last 2
weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simple
cold excluded

- History or evidence of clinically significant cardiac or cardiovascular disease

- History of deep vein thrombosis, pulmonary embolism or evidence of primary or
secondary hypercoagulable states

- History of surgical intervention for the treatment of tendinopathy, history of ankle
surgery, ankle arthritis, traumatic, inflammation or deformity of ankle

- History of full-thickness tear or complete rupture of the Achilles tendon